Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. recall: Sterility Concern
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906)…
Why was Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. recalled?
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025); b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025); c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026); d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026); e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026); f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025); g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026); h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026); i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026); j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026); k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026); l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026); m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026); n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025); o. Item No. 00784302006 (Lot Expiration Date Before 11/30/2025); p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026); q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026); r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025); s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026); t. Item No. 00784301756 (Lot Expiration Date Before 07/31/2025): u. Item No. 00784301836 (Lot Expiration Date Before 07/31/2026); v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026); w. Item No. 00784301856 (Lot Expiration Date Before 06/30/2026); x. Item No. 00784301946 (Lot Expiration Date Before 07/31/2026); y. Item No. 00784301956 (Lot Expiration Date Before 09/30/2025); z. Item No. 00784302046 (Lot Expiration Date Before 07/31/2026); aa.Item No. 00784302056 (Lot Expiration Date Before 07/31/2026); ab. Item No. 00784302146 (Lot Expiration Date Before 07/31/2026); ac. Item No. 00784302156 (Lot Expiration Date Before 07/31/2026); ad. Item No. 00784302246 (Lot Expiration Date Before 07/31/2026); ae. Item No. 00784302256 (Lot Expiration Date Before 07/31/2026)
- Product
- Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906)…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 38,069 units total
- Distribution
- Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
- Recall date
- March 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)